Therapeutic management of chronic spontaneous urticaria in clinical practice: results from a pilot survey.

BACKGROUND: The therapeutic approaches to patients with chronic spontaneous urticaria (CSU) differ among health care professionals and may be influenced by many factors. This cross-sectional survey was aimed at evaluating physicians' attitudes regarding therapeutic management of CSU in clinical practice. METHODS: A study-specific questionnaire was administered to a group of physicians (N.=21) with a specialist interest in CSU from different areas of Italy (group A) and also to other physicians (N.=25) who manage CSU only occasionally in their clinical activity (group B). RESULTS: In case of ineffectiveness of second-generation antihistamines at standard doses, higher doses of the same drug were always or frequently prescribed by most physicians in both groups, and 64% in group B and one third in group A usually increased the dose up to twice. Old-generation antihistamines were never used in clinical practice by 14% of survey participants in group A and 24% in group B, with the remaining physicians reporting rare or occasional uses. The prescription of systemic corticosteroids appeared to be more common among physicians in group B. The question concerning the use of alternative drugs in refractory CSU produced different answers between the two groups. Costs and access to specialist reference centers were indicated as the most important barriers to the use of medications different from antihistamines. CONCLUSIONS: These preliminary results suggest that therapeutic approaches to CSU seem to be heterogeneous in clinical practice and could be at least in part conditioned by the different medical settings where physicians usually work.

Chronic spontaneous urticaria in clinical practice: a pilot survey about attitudes and perceptions on assessment, diagnostic work-up and dietary management.

BACKGROUND: Chronic spontaneous urticaria (CSU) is a heterogeneous condition whose management can be complex and challenging. The aim of this study is to evaluate physicians' attitudes regarding practical aspects of CSU management, including adherence to international guidelines, criteria and instruments for CSU assessment, prescription of laboratory investigations and role of dietary measures. METHODS: A cross-sectional survey was conducted using a study-specific questionnaire. It was administered to a group of physicians with a specialist interest in CSU from different areas of Italy definable as "CSU experts" (group A; N.=21) and subsequently to other physicians who managed CSU only occasionally in their clinical activity (group B; N.=25). RESULTS: The EAACI/GA2LEN/EDF/WAO guidelines were considered very or moderately useful by the majority of participants. Significantly more physicians in group A reported that such guidelines were always followed in clinical practice (P=0.0008). Instruments for the assessment of CSU severity/activity and quality of life were used in clinical practice significantly more often by CSU experts as compared to group B. Dietary measures were frequently suggested for CSU patients by nearly three quarters of group B members and by only 5% of CSU experts (P<0.00001). When physicians were asked to indicate the type of laboratory examinations that were commonly performed in patients with longstanding and/or uncontrolled CSU, regardless of history, the investigations most frequently reported were full blood count and thyroid autoantibodies, followed by erythrocyte sedimentation rate and/or C-reactive protein and thyroid function tests. CONCLUSIONS: The results of the present pilot survey seem to suggest the heterogeneity of the approaches used for CSU management in clinical practice.

A retrospective study on clinical subtypes and management of morphea in 10 Italian Dermatological Units.

BACKGROUND: There are still few dermatological studies on morphea. We evaluated the epidemiological and clinical features and management of pediatric morphea, reporting dermatologists experience. METHODS: A multicenter retrospective observational study was carried out on the epidemiological and clinical features and management of the disease between 01/01/2009 and 01/10/2014 in 10 Italian Dermatological Units. RESULTS: We collected the data of 69 children affected by: circumscribed morphea (39.1%); linear morphea of trunk and limbs (14.5%); en coupe de sabre morphea (ECDS) (14.5%); progressive facial hemiatrophy (8.7%); generalized form (18.8%); mixed morphea (4.4%). The mean age at onset was 6.86±3.21 years, mainly between 2 and 8 years, but is statistically significantly lower for ECDS (4.5±3.03). Localizations were: head/neck (30.4%), limbs (26.1%), trunk (14.5%), 2 or more sites (29%), most often the trunk plus limbs. Extracutaneous manifestations were observed in 26.1% patients. 10 patients presented a second autoimmune disorder. Treatments were topical in 26.1% cases and systemic (alone or associated with topical treatments) in 68.1%. CONCLUSIONS: There was a lack of uniformity in the management of patients and an increasing awareness of dermatologists on the use of systemic therapies, in particular of methotrexate, which is no longer exclusive to rheumatologists. Methotrexate causes stabilization and improvement of the clinical signs, but topical creams are still considered adjuvant or maintenance therapies during/after the use of systemic drugs.

Omalizumab in Chronic Spontaneous Urticaria Refractory to Conventional Therapy: An Italian Retrospective Clinical Analysis with Suggestions for Long-Term Maintenance Strategies.

INTRODUCTION: Omalizumab is indicated for the treatment of patients affected by chronic spontaneous urticaria (CSU) refractory to antihistamines. The aim of this study was to assess the efficacy, safety, and recurrence of symptoms in a real-life experience of omalizumab as an add-on therapy for H1-antihistamine-refractory CSU patients (refractory CSU). METHODS: A retrospective review of the clinical records of all refractory CSU treated with omalizumab at our dermatology center from June 2014 to April 2017 was performed. Patients previously treated with second-generation antihistamines at a fourfold increased dose without clinical responses at 4 weeks of treatment were selected. Omalizumab was administered at a single dosage of 300 mg every 4 weeks for 6 months. Disease severity was assessed using the 7-day Urticaria Activity Score (UAS7). RESULTS: Eighteen patients (14 women; mean age 51 years, range 25-74) were enrolled. Mean UAS7 at baseline was 27.3 (range 15-38). Symptoms improved in all patients at 4 weeks (UAS7 = 16.1, range 0-36). Treatment was completed in 17 patients (94.4%), and among these, a complete response (UAS7 = 0) was registered in 10 patients (58.8%). Adverse events included thrombocytopenia in 1 patient (5.6%) at 16 weeks; therapy was suspended after 20 weeks and the complication was resolved, resulting in a freedom from major adverse events of 94.4%. Symptom recurrence occurred in 3 patients (17.6%) at 4, 5, and 7 months from the end of the primary therapy. Retreatment with omalizumab was successful without any adverse effects. Mean follow-up was 9.5 months (range 1-28). CONCLUSION: Add-on omalizumab therapy for refractory CSU in a real-life setting seems to be effective and safe with a relatively low incidence of symptom recurrence. Further research should investigate personalized omalizumab treatment dosages and administration intervals, and the identification of biomarkers for future treatment algorithms.

Critical appraisal of the unmet needs in the treatment of chronic spontaneous urticaria with omalizumab: an Italian perspective.

PURPOSE OF REVIEW: The humanized anti-IgE antibody omalizumab has been available for patients with chronic spontaneous urticaria (CSU) in Italy since 2015. This review summarizes the unresolved issues and unmet therapeutic needs associated with omalizumab and discusses practical recommendations for its use in the management of CSU. RECENT FINDINGS: Although modern second-generation H1-antihistamines are the standard of care for patients with CSU, adjunctive treatments (including omalizumab) may be required for effective control of symptoms in many patients. Evidence from clinical trials and experience from daily clinical practice suggest that the use of omalizumab in patients with CSU who have inadequate response to H1-antihistamines remains challenging. SUMMARY: Based on current international guidelines, omalizumab labelling information and our experience in clinical practice, we provide treatment recommendations regarding the use of omalizumab in patients with CSU. These include: optimal treatment duration, the use of concomitant antihistamine therapy, the definition and management of disease relapse after treatment, and the management of patients with late or no response to treatment.

Italian translation and validation of the Nordic Occupational Skin Questionnaire (NOSQ-2002).

BACKGROUND: Because of their frequent occurrence, in various situations it may be appropriate to carry out screening of skin disorders in groups of workers. For this purpose the self-administered standardized questionnaires are of great use. Among the best known is the Nordic Occupational Skin Questionnaire (NOSQ-2002), which had not yet been translated and validated in Italian. OBJECTIVES: The aim of the study was to translate the NOSQ-2002 into Italian and validate the resulting Italian version. METHODS: The original English text of the NOSQ-2002 was subjected to the ISPOR task force's procedures for translation and cultural validation of questionnaires in health care. Subsequently, the Italian version was tested on a sample of 52 individuals to assess comprehensibility and reliability through analysis of internal consistency and stability over time and the predictive value of the clinical history through assessment of sensitivity and specificity in 32 subjects. RESULTS: The Italian version of the NOSQ produced proved very true to the original, needing only minor changes. From interviews on the comprehensibility of the questionnaire no significant difficulties in understanding the text were detected. The results of the evaluation of internal consistency (Cronbach's Alpha: 0.88 and 0.97) and stability (K Cohen> 0.81 in 52/57 items) indicated that the Italian version of the NOSQ may be considered reliable for the purposes proposed. There were also excellent sensitivity and specificity results, which were 86% and 89% respectively. CONCLUSIONS: The Italian version of the NOSQ presented here is appropriate for self-administration and is reliable for use in studies on skin diseases in groups of workers.

Confocal microscopy insights into the treatment and cellular immune response of Basal cell carcinoma to photodynamic therapy.

BACKGROUND: Photodynamic therapy (PDT) represents an optimal treatment for basal cell carcinoma (BCC). Reflectance confocal microscopy (RCM) is a noninvasive imaging tool that has been applied in skin oncology and for BCC diagnosis. Moreover, RCM is a useful tool to determine noninvasive treatment efficacy of nonmelanoma skin cancer. OBJECTIVE: We aimed to investigate the role of RCM in assessing the efficacy of PDT in the treatment of BCC and to evaluate the skin changes following the PDT. METHODS: Ten patients with 12 BCCs were treated with PDT. Dermoscopy and RCM imaging were performed at baseline as well as 7 days (T1), 30 days and 18 months after PDT. Cytological examination was taken at baseline and in case of BCC persistence. RESULTS: At T1, RCM showed the presence of several dendritic-shaped cells within the epidermis, corresponding to activated Langerhans cells. After 1 month, RCM showed the persistence of 2 BCCs, which escaped the clinical and dermoscopic diagnosis. At the long-term follow-up, none of the tumors revealed signs of persistence or recurrence. CONCLUSION: RCM is a valuable noninvasive tool for the diagnosis and treatment monitoring of BCC using PDT.

Pigmented nodular Basal cell carcinomas in differential diagnosis with nodular melanomas: confocal microscopy as a reliable tool for in vivo histologic diagnosis.

Nodular basal cell carcinoma, especially when pigmented, can be in differential diagnosis with nodular melanomas, clinically and dermoscopically. Reflectance confocal microscopy is a relatively new imaging technique that permits to evaluate in vivo skin tumors with a nearly histological resolution. Here, we present four cases of challenging nodular lesions where confocal microscopy was able to clarify the diagnosis.

Psoriasis vs allergic contact dermatitis in palms and soles: a quantitative histologic and immunohistochemical study.

A systematic histologic and immunohistochemical study of cases of psoriasis (PSO) and allergic contact dermatitis (ACD) in palmo-plantar skin was performed to find differences between these two diseases that usually show overlapping features in these specific sites. Skin biopsies from 42 (22 female, 20 male) patients were evaluated for several histopathologic parameters and immunohistochemistry was applied to quantify keratinocytic proliferation, the number of dendritic cells (DCs) and the phenotype of the mononuclear cell infiltrate. Regular epidermal hyperplasia and marked parakeratosis were found to be more frequent in PSO than in ACD cases, but only the first parameter reached the level of significance (p = 0.03). The number of S100 protein-positive DCs was significantly higher in ACD (p = 0.006), whereas keratinocytic proliferation, studied with Mib-1, was found to be higher in PSO than in ACD, but the difference was not statistically significant. No significant difference was detected in the number of CD4+, CD8+ and bcl2+ lymphocytes in PSO and ACD cases. In the palms and soles, the finding of irregular epidermal hyperplasia and the detection of a higher number of S100 protein-positive DCs favor the diagnosis of ACD over PSO. The differential diagnosis between PSO and ACD can be practically approached using a histopathologic parameter and a commercially available antibody.

Contact sensitization in 1094 children undergoing patch testing over a 7-year period.

Contact sensitization in children is frequent. However, because exposure to sensitizing agents varies rapidly, it is of utmost importance to perform a periodic evaluation of patch test results. Our purpose was to compare our data on contact sensitization in children during the past 7 years to our previous 1988-1994 findings, in order to identify emerging allergens and update our pediatric series. From 1995 to 2001, 1094 consecutive children were examined. Of these, 997 patients were patch tested with our pediatric series, which includes 30 allergens, whereas 97 underwent patch testing with 46 allergens. A total of 570 children proved allergic (52.1%). The highest sensitization rate was observed in children under 3 years of age. No differences between atopic dermatitis patients and nonatopic ones were observed in the sensitization rate. Neomycin, nickel, wool alcohols, thimerosal, and ammoniated mercury gave most of the positive responses. With respect to 1988-1995 data, allergy to substances such as neomycin, nickel, wool alcohols, thimerosal, ammoniated mercury, propolis, potassium dichromate, and thiuram mix proved more frequent. In conclusion, as sensitization rates to different allergens show great variations over time, periodic evaluations of patch test results in children is necessary in order to update the test trays.

Sensitization to propolis in 1255 children undergoing patch testing.

To investigate the frequency and the features of contact sensitization to propolis in children, we patch tested 1255 consecutive children suspected of allergic contact dermatitis with propolis 20% petrolatum over an 8-year period (1995-2002). Positive responses were observed in 5.9% of patch-tested subjects, with a significantly higher frequency in boys than in girls. The dermatitis was localized mainly on the face, hands and limbs. A significant linear increase in the annual frequency of propolis allergy was noted. Confirming literature data, a significant association with balsam of Peru sensitivity was present in children reacting to propolis, linked to the presence of common constituents in the 2 substances. In conclusion, based on our data, we suggest that propolis should not be used in topical products for children because of its high sensitization rate at the paediatric age.